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Dose of Spinal Manipulation for Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mitchell Haas, University of Western States
ClinicalTrials.gov Identifier:
NCT00376350
First received: September 12, 2006
Last updated: June 6, 2014
Last verified: June 2014

September 12, 2006
June 6, 2014
March 2007
July 2011   (final data collection date for primary outcome measure)
  • Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Modified Von Korff Pain Scale for low back pain
  • Modified Von Korff Disability Scale
Complete list of historical versions of study NCT00376350 on ClinicalTrials.gov Archive Site
  • Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
  • Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Objective measures [ Time Frame: Baseline 2, 6 wk ] [ Designated as safety issue: No ]
  • Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Pain days
  • Disability days
  • Low back pain unpleasantness
  • Fear avoidance beliefs
  • General health status/QoL
  • Patient satisfaction
  • Healthcare utilization
  • Objective measures
  • Bias monitoring
Not Provided
Not Provided
 
Dose of Spinal Manipulation for Chronic Low Back Pain
Dose-Response/Efficacy of Manipulation for Chronic LBP

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Back Pain
  • Procedure: Spinal Manipulation
    5 minutes high velocity, low amplitude lumbar thrust
  • Procedure: Light Massage
    light pressure massage of the low back.
  • Procedure: Pulsed Ultrasound
    5 minutes pulsed ultrasound
  • Experimental: High dose manipulation
    High dose spinal manipulation + ultrasound
    Interventions:
    • Procedure: Spinal Manipulation
    • Procedure: Pulsed Ultrasound
  • Experimental: Moderate dose manipulation
    Moderate dose manipulation + low dose massage + ultrasound
    Interventions:
    • Procedure: Spinal Manipulation
    • Procedure: Light Massage
    • Procedure: Pulsed Ultrasound
  • Experimental: Low dose manipulation
    low dose spinal manipulation + moderate dose massage + ultrasound
    Interventions:
    • Procedure: Spinal Manipulation
    • Procedure: Light Massage
    • Procedure: Pulsed Ultrasound
  • High dose masssage
    high dose massage + ultrasound
    Interventions:
    • Procedure: Light Massage
    • Procedure: Pulsed Ultrasound

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current episode of low back pain
  • mechanical origin
  • Threshold low back pain level

Exclusion Criteria:

  • Contraindications to spinal manipulation or massage
  • Complicating conditions that could confound clinical outcome
  • Prophylactic use of prescription medication
  • Health-related litigation, claims, or disability compensation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00376350
U01 AT001908, U01AT001908
Yes
Mitchell Haas, University of Western States
University of Western States
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Mitchell Haas, DC, MA University of Western States
University of Western States
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP